2022 Digital CMC Summit: Exploring the Future of High-Performance Drug Development

Miss the live event? Stream all 8 sessions from this year’s summit on-demand, including in-depth presentations, panel discussions, Q&A, and more.


For 3 days in November 2022, Austin, TX, became the center of a technological revolution sweeping life sciences.

The 1st Annual Digital CMC Summit brought together future-focused professionals from across the industry to explore a new digital frontier of drug development. Over 100 experts from 16 organizations joined us for this groundbreaking event, and left inspired to help define the next data-driven chapter of our industry.

Stream all 8 expert-led sessions from the 2022 summit.

This first-of-its-kind conference featured a world-class roster of luminary speakers specializing in process development, quality, compliance, manufacturing, data science, and more. Couldn’t make it to Austin to hear them live? You can stream their presentations at any time:

Digital Transformation of CMC: The Process is Already Underway

See why the CMC process is the ideal place to harness the digital momentum sweeping the industry.

Transforming the CMC Lifecycle: Why the Biopharma Industry Can’t Afford to Wait

Find out how new industry dynamics are driving transformation across the entire product lifecycle, from molecule to patient.

Lifecycle Approaches for Robust Control Strategies

Take an in-depth look at how cutting-edge data management techniques are unlocking the potential of digital twins for CMC.

Driving Efficiency in CMC Operations

Learn how CMC leaders are developing their innovation strategies and creating a case for change within their organizations.

Real-World Digital CMC Use Cases

Go behind the scenes of multiple successful rollouts with the industry visionaries who planned and led them.

The Evolving Digital CMC Ecosystem

Explore the growing range of technologies and workflows that are shaping the next generation drug development.

Digital CMC, Validation & Quality Management

See how new process validation, data integrity, and quality management modalities are advancing CMC maturity.

Accelerating MES Implementation

Discover how Digital CMC solutions can help streamline the transition to core commercial manufacturing platforms.

CMC transformation: The time is now

For 2022 summit attendees, one urgent theme echoed across disciplines, departments, and specialties: it’s never been more important for drug developers to break down their siloes and share the effort of digitizing drug development.

They came together to explore how life sciences businesses need to evolve and adapt as they navigate the transition from legacy processes to data-centric, digitally native CMC. With operational and regulatory pressures mounting on their organizations, the featured speakers cut straight to some of the most critical challenges facing today’s CMC programs:

  • Building a holistic transformation strategy and compelling value case
  • Gaining and maintaining cross-functional buy-in for transformation initiatives
  • Aligning priorities and harmonizing efforts across disciplines and unit operations
  • Enhancing technological integration across the product life cycle
  • Unifying, structuring, and unlocking the value of CMC data


The future of CMC data loomed large: how and when will drug developers finally tap the full potential of their immense information resources? New technologies, strategies, and methodologies are already on the way – but as many pointed out, an array of critical barriers still stand in the way of these innovations and their impact.

After three days of rich presentations, deep-dive discussions, and valuable networking, guests left energized, inspired, and stocked with new ideas for driving the transformation process. We can’t wait to see where it takes them and their organizations.

"The Digital CMC Summit is everything you want in an industry event: focused, forward-thinking, and insight-rich. It's a fantastic opportunity for CMC professionals to explore the cutting edge of their domain."

Looking ahead to the 2023 Digital CMC Summit

The inaugural summit broke new ground, started countless important conversations, and created many new connections. But with so much left to achieve, we’re already looking ahead at how we sustain the momentum, continue those discussions, and keep the focus on how drug developers can achieve true, sustainable CMC transformation.

Our next step: spark even more of this year’s chemistry (and manufacturing, and controls) with a new chapter of the Digital CMC Summit experience. The stars are already aligning for an exciting new evolution of this one-of-a-kind conference – so get ready to mark your calendar, save the date, and book your travel in the next few weeks!

Big 2023 updates are coming soon. Be the first to know!

Next year’s summit will be a can’t-miss event for drug digitally savvy development professionals. Sign up today to stay up to the minute!

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Life Sciences Luminary and Influencer

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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Speaker’s Pretty Long Title, Specialty, and Business

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